EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN 868-6 testing. This standard provides test methods and values for paper used in the manufacture of preformed sterile barrier systems or packaging systems that are intended to maintain the sterility of ultimately sterilized medical devices up to the point of use.
The need for protective packaging can be determined by the manufacturer and the user.
This part of EN 868 only presents the performance requirements and test methods specific to the products covered by this part of EN 868, but does not add or replace the general requirements set out in EN ISO 11607-1.
Therefore, the specific requirements in 4.2 to 4.3 can be used to demonstrate compliance with one or more, if not all, of the requirements in EN ISO 11607-1.
The paper specified in this part of the EN 868 series is intended for use in the partial or total manufacture of bags and form and fill packs and closure materials for packs.
The paper specified in this part of the EN 868 series is suitable for the manufacture of sterile barrier systems to be used in ethylene oxide, irradiation or low temperature steam formaldehyde sterilization processes and for the production of coated paper according to EN 868-7.
When additional materials are used within the sterile barrier system to facilitate organization, drying, or aseptic presentation (e.g., inner wrap, container filters, gauges, packing lists, mats, instrument organizer kits, tray liners, or an additional envelope around the medical device) then validation Other requirements may apply, including determining the acceptability of these materials during their operations.
EUROLAB assists manufacturers with EN 868-6 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
